Efficacy and Safety of VDPHL01 in Males With AGA

This study will evaluate the safety and efficacy of VDPHL01 in male subjects with Androgenetic Alopecia (AGA).

AGA (or male pattern baldness) is a genetic disorder caused by an excessive (too much) hair follicle response to androgens (hormone) that causes hair loss. VDPHL01 8.5 mg Tablet is an investigational oral drug to treat male pattern baldness.

This multi-center, double blind, study will last about 13 months and includes 11 study visits (screening, baseline (day 1), week 2, month 1, month 2, month 4, month 6, month 8, month 10, month 12, month 13).

The first 7 visits will be part of the placebo-controlled period. The next 3 visits will be part of the treatment extension phase. All subjects will receive active drug in the treatment extension phase.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Androgenetic Alopecia AGA Alopecia Hair Diseases Hypotrichosis Male Pattern Baldness Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Site 36, Birmingham, Alabama, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subject is male aged 18-65 years old;
Subject has a clinical diagnosis of mild to moderate AGA;
Subject is in good general health and has normal renal and hepatic function;
Subject is willing to maintain at least 1/4 inch length hair during the study with the same hairstyle, hair length, and hair color throughout the study; maintain consistent use of general hair care products and regimen through the entire study;
Subject is willing and able to administer the test article as directed read, understand, and complete required questionnaires in English;
Subject is willing and able to swallow study drug whole;
Subject agrees to have a micro dot tattoo placed on their scalp;
Subject agrees to have this area photographed at study visits as indicated in the protocol.

Exclusion criteria

Subject has uncontrolled blood pressure or orthostatic hypotension;
Subject has symptoms or history of certain heart or thyroid conditions;
Subject has a history of or active hair loss due to conditions/diseases other than AGA;
Subject has a current or recent history of dietary or weight changes, including use of GLP-1 agonists;
Subject has been diagnosed with COVID-19 within 16 weeks of screening;
Subject has had previous radiation of the scalp;
Use of any of the following treatments within the indicated washout period before screening:

Subject has used hormone replacement therapy or hormonal modulators within 6 months prior to screening
Subject has used oral treatments for hair growth or that can affect hair growth, including systemic retinoids, within 6 months of screening
Subject has used systemic calcium channel blockers or beta blockers within 12 weeks prior to screening
Subject has used systemic cimetidine, ketoconazole, diazoxide, or corticosteroids (including intramuscular, intraarticular, and intralesional injections) within 12 weeks prior to screening
Subject has had any scalp procedures, including surgical, laser, light or energy treatments, micro-needling, injections, platelet rich plasma within 6 months prior to screening
Subject has used any topical scalp treatments for hair growth within 12 weeks prior to screening
Subject has used any other therapy with any medication either topical or oral that might, in the investigator's opinion, interfere with the study;
Subject has any other condition that, in the investigator's opinion, interfere with the study

Treatment and study plan

VDPHL01

Drug

VDPHL01 Extended Release (ER) Tablet

Placebo

Drug

Placebo

Primary outcomes

Changes in non-vellus Target Area Hair Counts (TAHC)

Time frame: Month 6

Change from baseline in non-vellus TAHC using digital image analysis at Month 6.
Subjects Evaluation of Treatment Benefit

Time frame: Month 6

Subjects will rate their treatment benefit by responding to a hair assessment scale. The proportion of subjects by each response category will be reported at Month 6.

Sponsors and collaborators

Lead sponsor

Veradermics, Inc.

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-dose Study to Evaluate the Efficacy and Safety of VDPHL01 in Male Subjects With Androgenetic Alopecia

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Dec 9, 2024
Registry last updated: Nov 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting